UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059937 |
|---|---|
| Receipt number | R000068546 |
| Scientific Title | Research study on changes in blood sugar levels, weight, and body fat due to mulberry green juice |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/12/01 21:56:25 |
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Basic information
Public title
Research study on changes in blood sugar levels, weight, and body fat due to mulberry green juice
Acronym
Research study on changes in blood sugar levels, weight, and body fat due to mulberry green juice
Scientific Title
Research study on changes in blood sugar levels, weight, and body fat due to mulberry green juice
Scientific Title:Acronym
Research study on changes in blood sugar levels, weight, and body fat due to mulberry green juice
Region
| Japan |
Condition
Condition
Target condition (Condition) Healthy subjects and pre-symptomatic subjects (pre-metabolic syndrome, subjects with high blood glucose levels)
Classification by specialty Internal Medicine (Metabolism / Endocrinology)
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratorily evaluate the effects of 4-week continuous intake of "Tenku Kuwa Aojiru" (Mulberry Green Juice) on biomarkers related to metabolic syndrome and diabetes (specifically postprandial blood glucose), as well as body weight and body fat percentage. Focusing on the effect of iminosugars, a component unique to mulberry leaves, to moderate sugar absorption, this pilot study verifies its usefulness in healthy individuals and those in the borderline range.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in postprandial blood glucose levels (comparison between pre-intake and 4 weeks post-intake)
Changes in body weight, body fat percentage, and BMI (comparison between pre-intake and 4 weeks post-intake)
Key secondary outcomes
Changes in blood biochemical parameters (HbA1c, Triglyceride, Total cholesterol, HDL cholesterol, Uric acid, Total protein, Albumin, AST, ALT, gamma-GT, BUN, Creatinine)
Changes in subjective physical conditions via questionnaire (stomach condition, skin condition, quality of awakening, other subjective symptoms)
Evaluation of product palatability and acceptability (ease of drinking, taste, intention to continue drinking)
Presence and details of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food "Tenku Kuwa Aojiru" (3g/pack) once daily for 4 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male
Key inclusion criteria
Males and females in their 20s to 70s
Subjects who understand the purpose and content of this study and provide written informed consent
(Blood glucose group only) Subjects capable of participating in blood sampling at the designated location
(Body weight group only) Subjects capable of measuring and recording body weight and body fat percentage at home
Key exclusion criteria
Subjects with a history of serious diseases such as kidney disease
Subjects taking medications or supplements unsuitable for the study
Subjects who are pregnant, lactating, or possibly pregnant
Subjects with an allergy to mulberry leaves
Subjects currently receiving treatment for diabetes (insulin injections or oral hypoglycemic agents)
Other subjects deemed inappropriate by the principal investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Fuchigami |
Organization
Atsumaru Holdings Co., Ltd.
Division name
NSP Yamaga Factory Production Management Department
Zip code
861-0602
Address
4041 Imo, Kahokucho, Yamaga City, Kumamoto Prefecture
TEL
0968-41-8680
fuchigami@atsumaru.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Fuchigami |
Organization
Atsumaru Holdings Co., Ltd.
Division name
NSP Yamaga Factory Production Management Department
Zip code
861-0602
Address
4041 Imo, Kahokucho, Yamaga City, Kumamoto Prefecture
TEL
0968-41-8680
Homepage URL
fuchigami@atsumaru.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yuurea Research Ethics Committee
Address
2-14-1 Nagoya, Nishi-ku, Nagoya, Aichi Prefecture Nagono Campus, 3F
Tel
050-3717-0358
ushijima.takuto@yuurea.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068546
